Providing Psychological and Emotional Support After Perinatal Loss: A Virtual Reality-Based Intervention

NCT ID: NCT04656977

Last Updated: 2020-12-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-16
• Study Completion Date: 2022-10-31

Brief Summary

The loss of an infant during the perinatal period has been recognized as a complex and potentially traumatic life event and can have a significant impact on women's mental health. However, often times, psychological aftercare is typically not offered, and manualized interventions are rarely used in clinical care practice and have seldom been evaluated. In recent years, a growing number of studies have demonstrated the efficacy of virtual reality (VR) interventions to facilitate the expression and coping with emotions linked to a traumatic event. The objective of the proposed paper is to present the protocol of a randomized control trial aimed to assess a novel VR-based intervention for mothers who experienced a perinatal loss. The investigators hypothesize that the VR-based intervention group will show significantly reduced symptoms related to grief, postnatal depression and general psychopathology after treatment relative to a treatment-as-usual (TAU) group. With the present study the investigators propose to answer to the unquestionable need for interventions addressed to ameliorate the emotional effects in women who experienced perinatal loss, by exploiting also the therapeutic opportunities offered by a new technology as VR.

Conditions

Grief; Perinatal

Keywords

Perinatal loss; Perinatal grief; Women mental health; Virtual reality; Psychological intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

VR+TAU

Participants will participate first to a VR-based intervention and then to the TAU condition. The TAU condition is a homogenous standard program proposed by the Centre d'études et de recherché en intervention familiale (CERIF) at Université du Québec en Outaouais (UQO) based on group counseling offered to women and men who experienced a perinatal loss.

Group Type: ACTIVE_COMPARATOR

VR

Intervention Type: OTHER

The proposed intervention will consist in three weekly sessions of 2h focused, respectively, on: (1) gathering information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the features of the virtual environment (i.e., a series of different virtual landscapes and symbolic elements personalized to each participant as personal pictures, sounds or videos) a new and positive metaphor representing the woman's future life.

TAU

Intervention Type: OTHER

The TAU condition is a homogenous standard program proposed by the CERIF at UQO based on group counseling offered to women and men who experienced a perinatal loss.

TAU+VR

Participants will be invited first to participate to the TAU condition and then to the VR-based intervention.

Group Type: ACTIVE_COMPARATOR

VR

Intervention Type: OTHER

The proposed intervention will consist in three weekly sessions of 2h focused, respectively, on: (1) gathering information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the features of the virtual environment (i.e., a series of different virtual landscapes and symbolic elements personalized to each participant as personal pictures, sounds or videos) a new and positive metaphor representing the woman's future life.

TAU

Intervention Type: OTHER

The TAU condition is a homogenous standard program proposed by the CERIF at UQO based on group counseling offered to women and men who experienced a perinatal loss.

Interventions

VR

The proposed intervention will consist in three weekly sessions of 2h focused, respectively, on: (1) gathering information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the features of the virtual environment (i.e., a series of different virtual landscapes and symbolic elements personalized to each participant as personal pictures, sounds or videos) a new and positive metaphor representing the woman's future life.

Intervention Type: OTHER

TAU

The TAU condition is a homogenous standard program proposed by the CERIF at UQO based on group counseling offered to women and men who experienced a perinatal loss.

Intervention Type: OTHER

Other Intervention Names

VR-based intervention; Group counseling

Eligibility Criteria

Inclusion Criteria

• Mothers who had recently experienced a perinatal death, including: having lost a child during pregnancy because of miscarriage (i.e., embryo or fetus death prior the 28th week of gestation); termination due to medical indications; stillbirth (i.e., fetus death after 28 completed weeks of gestation); or neonatal death (i.e., infant death within the first 7 days of life).
• Women who have experienced perinatal death while pregnant within no more than 1 year before the enrollment will be invited to participate to the study.

Exclusion Criteria

• Significant vision impairments despite wearing corrective glasses or lenses.
• Presence of a severe and disabling diagnosed mental disorder which requires immediate treatment.
• Being under psychological treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Research Chair in Family Psychosocial Health

UNKNOWN

Sponsor Role: collaborator

Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role: collaborator

Universite du Quebec en Outaouais

OTHER

Sponsor Role: lead

Responsible Party

Giulia Corno

Postdoctoral fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Université du Québec en Outaouais

Gatineau, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Giulia Corno, Ph.D.

Role: CONTACT

Phone: 819-595-3900

Email: giulia.corno@uqo.ca

Facility Contacts

Giulia Corno, PhD

Role: primary

References

Corno G, Bouchard S, Banos RM, Rivard MC, Verdon C, de Montigny F. Providing Psychological and Emotional Support After Perinatal Loss: Protocol for a Virtual Reality-Based Intervention. Front Psychol. 2020 Jun 10;11:1262. doi: 10.3389/fpsyg.2020.01262. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32587557 (View on PubMed)

Other Identifiers

2020-867

Identifier Type: -

Identifier Source: org_study_id